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Moleculin (MBRX) files 1-for-20 reverse stock split effective Oct 20, 2026
Moleculin (MBRX) filed to effect a 1-for-20 reverse stock split effective 12:01 AM ET on Oct 20, 2026, consolidating roughly 20.9M shares into ~1.05M shares; post-split shares will trade on Nasdaq under the same ticker with a new CUSIP and fractional shares will be paid out in cash. The company also disclosed it will require significant additional financing and currently has no commitments, a material funding risk for its ongoing clinical programs.
MBRX completes Part A enrollment in pivotal Phase 2/3 MIRACLE; Q1 2027 readout on track
Moleculin (MBRX) has closed enrollment in Part A of its pivotal Phase 2/3 MIRACLE trial in relapsed/refractory AML with 89 subjects enrolled (plus one in screening) and says it remains on track for a comprehensive Part A data readout in Q1 2027. Part A is a randomized, double-blind comparison of two doses of Annamycin + cytarabine versus cytarabine + placebo measured after a single cycle; company expects the full dataset to be ~50/50 between patients previously treated with intensive 7+3 and venetoclax-based regimens and reports continued absence of cardiotoxicity in blinded data.
Preclinical AACR data: Annamycin shows CD8+ T‑cell activity in pancreatic tumor models
Moleculin presented preclinical AACR data showing Annamycin’s antitumor effect in pancreatic cancer is partly mediated by CD8+ T cells, suggesting it may convert immunologically “cold” tumors to “hot” and enable immune‑based combination strategies. These results are preclinical only (not predictive of human outcomes), Annamycin is not in clinical development for pancreatic cancer, and the company's near‑term focus remains the MIRACLE Phase 2/3 AML trial.
Moleculin (MBRX) wins Mexican patent for lung-targeted liposomal Annamycin through 2040
Moleculin (MBRX) said the Mexican Patent Office granted Patent No. 436849, protecting its lung-targeted liposomal formulation of Annamycin until Nov. 23, 2040. The company says the patent strengthens Annamycin's global IP estate and supports potential development into pulmonary tumors and lung metastases while the drug advances in the pivotal MIRACLE Phase 2/3 trial for relapsed/refractory AML (Annamycin + cytarabine).
MBRX to present Annamycin tissue-distribution, topo II mechanism and CD8+ T-cell data at AACR & EU meetings
Moleculin (MBRX) will present new Annamycin (naxtarubicin) data at three September scientific meetings, including the AACR pancreatic cancer conference; presentations cover the drug's organotropism (tissue concentration), its topoisomerase II–targeting mechanism, and evidence that antitumor activity is partially mediated by CD8+ T cells in preclinical models. The AACR abstract is under embargo until Sept 25, and the company says these mechanistic/preclinical data complement — but do not replace — its ongoing MIRACLE Phase 2/3 program in relapsed/refractory AML, which remains the lead clinical focus.
MBRX prices $9.3M offering: 12.38M shares (or pre-funded warrants) + 37.13M warrants
Moleculin priced a best-efforts public offering of 12,376,667 shares of common stock (or pre-funded warrants in lieu thereof) with detachable Common Warrants to purchase up to 37,130,001 shares at a combined price of $0.75, implying gross proceeds of about $9.3M. The Common Warrants are immediately exercisable at $0.75, expire five years after issuance, and the offering is expected to close on or about August 3, 2026, subject to customary closing conditions; Roth Capital is the exclusive placement agent. Timing: The press release does not indicate dilution today; initial share dilution occurs at the offering close (Aug 3, 2026), and once the offering closes those shares have been issued.
MBRX MIRACLE interim blinded CRc 37% overall and in venetoclax-failed subgroup; enrollment 74/90
Moleculin (MBRX) reported preliminary blinded Part A results from the Phase 2/3 MIRACLE trial: among 62 evaluable patients AnnAraC (Annamycin + cytarabine) showed a blinded CR of 24% and CRc of 37%, and the 30-patient subgroup who failed first-line venetoclax had similar rates (CR 23%, CRc 37%) versus published salvage remission benchmarks of ~13%. The analysis is still blinded and includes control-arm patients; enrollment is 74/90 with final Part A treatment expected Sept 2026 and unblinded Part A results due Dec 2026–Feb 2027, and no cardiotoxicity signal has been observed to date.
MBRX: Blinded MIRACLE interim CRc 37% overall and 37% in venetoclax-failed subgroup; Part A 74/90, full readout Dec 2026–Feb 2027
MBRX filed SEC Form 8-K. Enrollment is at 74 of 90 patients with the company expecting to treat the 90th subject in September 2026 and to unblind comprehensive Part A data in December 2026–February 2027; the filing also reports no evidence of cardiotoxicity and notes the analysis is blinded (includes control-arm patients) and preliminary.
MBRX: CEO flags positive preliminary Phase 2/3 MIRACLE Annamycin efficacy in first 45 patients
Moleculin CEO Walter Klemp presented positive preliminary unblinded efficacy trends from the first 45 patients in Part A of the pivotal Phase 2/3 MIRACLE trial of Annamycin + cytarabine (AnnAraC) in relapsed/refractory AML and discussed commercial potential and market research. These are early, unblinded results from a small sample (n=45) that have not reached statistical significance and remain subject to further review; the company says prior Phase 1B/2 work and FDA input have helped de-risk the program but will require significant additional financing to complete development.
MBRX: Early positive unblinded efficacy trends reported from first 45 patients in MIRACLE Phase 2/3
Moleculin's CEO said preliminary unblinded efficacy trends from the first 45 patients in Part A of the pivotal Phase 2/3 MIRACLE trial of Annamycin (AnnAraC) in relapsed/refractory AML look positive and discussed commercial opportunity and market research. The company cautioned the interim n=45 dataset is small, unblinded and not statistically significant, is subject to further review and follow-up, and it will require additional financing with no commitments.
Moleculin Annamycin shows ~3x CR vs control in Phase 2/3 MIRACLE interim (n=45)
Moleculin reported unblinded interim results from the first 45 patients in Part A of the Phase 2/3 MIRACLE trial: both Annamycin arms achieved complete remission rates of 43% and 36% versus 12% for the HiDAC control, and CRc of 50% and 57% versus 29% for control — all measured after a single treatment cycle. The trial's Independent Data Monitoring Committee found a strong numeric trend favoring Annamycin, recommended continuing the study without dropping either dose, and Part A is ~74% enrolled (67/90) with the selected dose to carry forward into the pivotal portion.
Survey shows strong physician intent to prescribe Moleculin's Annamycin in R/R AML
Independent market research found hematologist‐oncologists gave Annamycin an average likelihood‐to‐prescribe score of 6/7 in relapsed/refractory AML, citing reported deep and MRD‐negative remissions, transplant‐bridging potential, biomarker‐agnostic use and reduced cardiotoxicity as adoption drivers. Payers interviewed also viewed the drug's efficacy/safety profile and broad applicability favorably; the study is qualitative and directional (not predictive), no new clinical efficacy data were released, and Annamycin is advancing in a pivotal adaptive Phase 2b/3 (MIRACLE) trial following prior Phase 1B/2 results.
MBRX: ASCO pooled data show no detectable cardiotoxicity with Annamycin despite very high cumulative doses
Moleculin (MBRX) presented a pooled ASCO 2026 analysis of 90 patients (78 with paired LVEF) showing no detectable cardiotoxicity with Annamycin despite median cumulative exposure of 660 mg/m2 and individual exposures up to 2,970 mg/m2; an independent Cleveland Clinic review found no LVEF decline, ECG/biomarker or strain signals. The company highlighted prior Phase 1b/2 AML efficacy (CR 50%, CRc 60%, median OS 12.39 months) and said the safety data support its ongoing pivotal Phase 2b/3 MIRACLE trial, with unblinding of the first 45 patients on track for June 2026.